Artemisinin-Based Antimalarial Combinations and Clinical Response in Cameroon

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 42 days follow up period in 720 children with acute uncomplicated P. falciparum malaria, in two different endemic ecological areas - Savanna and equatorial forest regions of Cameroon.

We have set as specific objectives:

• To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 14 and 28 days follow up period in children with acute uncomplicated P. falciparum malaria in two different endemic areas.

• To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 42 days follow up period in children with acute uncomplicated P. falciparum malaria.

• To determine parasite clearance time (PCT) and fever clearance time (FCT) following the administration of the three trial regimens.

• To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in all groups after trial.

• To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of genes associated with drug resistance

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Yaounde 1
• Collaborators: Gates Malaria Partnership; World Health Organization
• Treatments: Amodiaquine; Antimalarials; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinine; Artemisinins; Artenimol; Artesunate; Dihydroartemisinin; Lumefantrine; Piperaquine

Criteria

Inclusion Criteria:

• Children of either gender, aged between 6 months (> 5kg) and 10 years.

• Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 1,000 to 100,000 parasites/μl.

• Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in the preceding 24 hours.

• Able to ingest tablets orally (either suspended in water or uncrushed with food).

• Willing to participate in the study with written assent from parent/guardian. Parental authorization will be obtained for children less than 8 years old and documented assent of parents/guardians for children 8-10 years.

• Willing and able to attend the clinic on stipulated regular follow-up visits.

Exclusion Criteria:

•Any of the following "danger signs of severe malaria": Not able to drink or breast feed Persistent vomiting (>2 episodes within previous 24 hours) Convulsions (>1 episode within previous 24 hours) Lethargic/unconscious

• Signs/symptoms indicating severe/complicated malaria according to WHO criteria (WHO definition).

• Concomitant illnesses, underlying chronic hepatic or renal disease, abnormal cardiac rhythm, hypoglycaemia, jaundice, respiratory distress,

• Serious gastrointestinal disease, severe malnutrition (W/H < 70%) or severe anaemia (haemoglobin < 5 g/dl).

• Known hypersensitivity to the study drugs.